Janssen Biotech, Inc.
NDC labeler code: 57894
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- UstekinumabWezlana, Pyzchiva, Starjemza · 6 products
- Amivantamab and hyaluronidase-lpuj (human recombinant)Rybrevant Faspro · 4 products
- GuselkumabTremfya · 3 products
- GolimumabSimponi, Simponi Aria · 3 products
- InfliximabRemicade, Renflexis, Inflectra · 2 products
- Talquetamab-tgvsTalvey · 2 products
- LazertinibLazcluze · 2 products
- Nipocalimab-aahuImaavy · 2 products
- Teclistamab-cqyvTecvayli · 2 products
- Niraparib tosylate monohydrate and abiraterone acetateAkeega · 2 products
- Abiraterone acetateZytiga, Abirtega, Yonsa · 2 products
- DaratumumabDarzalex IV, Darzalex · 2 products
- IcotrokinraIcotyde · 1 product
- Daratumumab and hyaluronidase-fihj (human recombinant)Darzalex Faspro · 1 product
- GemcitabineAvgemsi, Inlexzo · 1 product
- Amivantamab-vmjwRybrevant · 1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| March 17, 2026 | NDA220149 | Icotrokinra ICOTYDE | Janssen Biotech |
| December 17, 2025 | BLA761433 | Amivantamab and hyaluronidase-lpuj (human recombinant) RYBREVANT FASPRO | Janssen Biotech |
| September 9, 2025 | NDA219683 | Gemcitabine INLEXZO | Janssen Biotech |
| April 29, 2025 | BLA761430 | Nipocalimab-aahu IMAAVY | Janssen Biotech |
| August 19, 2024 | NDA219008 | Lazertinib LAZCLUZE | Janssen Biotech |
| August 11, 2023 | NDA216793 | Niraparib tosylate monohydrate and abiraterone acetate AKEEGA | Janssen Biotech |
| August 9, 2023 | BLA761342 | Talquetamab-tgvs TALVEY | Janssen Biotech |
| October 25, 2022 | BLA761291 | Teclistamab-cqyv TECVAYLI | Janssen Biotech |
| May 21, 2021 | BLA761210 | Amivantamab-vmjw RYBREVANT | Janssen Biotech |
| May 1, 2020 | BLA761145 | Daratumumab and hyaluronidase-fihj (human recombinant) DARZALEX FASPRO | Janssen Biotech |
| July 13, 2017 | BLA761061 | Guselkumab TREMFYA | Janssen Biotech |
| September 23, 2016 | BLA761044 | Ustekinumab STELARA | Janssen Biotech |
| November 16, 2015 | BLA761036 | Daratumumab DARZALEX | Janssen Biotech |
| July 18, 2013 | BLA125433 | Golimumab SIMPONI ARIA | Janssen Biotech |
| April 28, 2011 | NDA202379 | Abiraterone acetate ZYTIGA | Janssen Biotech |
| September 25, 2009 | BLA125261 | Ustekinumab STELARA | Centocor Ortho Biotech Inc |
| April 24, 2009 | BLA125289 | Golimumab SIMPONI | Centocor Ortho Biotech Inc |
| August 24, 1998 | BLA103772 | Infliximab REMICADE | Centocor Inc |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2026
-
September 23, 2026 · Class II · Ongoing · D-0016-2027 · Nipocalimab-aahu
Presence of particulate matter.
IMAAVY (nipocalimab-aahu) Injection, 300 mg /1.62 mL (185 mg/mL) per single-dose vial, For Intravenous Infusion After Dilution, Rx only, Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044. NDC: 57894-800-01
2021
-
March 9, 2021 · Class III · Terminated · D-0314-2021 · Guselkumab
Temperature Abuse
Tremfya (guselkumab) Injection, 100 mg/mL, one single-dose prefilled syringe per carton, Rx only, Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044; NDC 57894-640-01.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Next steps
- Find a pharmacy near youAsk which company made your medicine and whether it is recalled
- Latest FDA drug recallsAll companies, newest first
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- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026